Due to a growing and ageing population, demand for medical devices is ever-increasing. By 2030, GlobalData forecasts the medical devices market to reach a value of $700bn. As the industry grows, there is an increasing focus on quality management across the manufacturing and use of its products.
This is where regulatory bodies such as the International Organization for Standardization (ISO) come in. To ensure all medical devices meet the proper regulatory compliance laws, ISO developed ISO 13485, an internationally agreed standard that sets out the requirements for a quality management system (QMS) specific to medical device manufacturing.
